1 EN 
 
 2  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels,  
  
Draft 
COMMISSION DECISION 
of 
concerning the non-inclusion of nicotine in Annex I to Council Directive 91/414/EEC 
and the withdrawal of authorisations for pl ant protection products containing that 
substance  
(Text with EEA relevance) 3 Draft 
COMMISSION DECISION 
of 
concerning the non-inclusion of nicotine in Annex I to Council Directive 91/414/EEC 
and the withdrawal of authorisations for pl ant protection products containing that 
substance  
(Text with EEA relevance)  
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty esta blishing the European Community, 
Having regard to Council Dir ective 91/414/EEC of 15 July 1991 concerning the placing of 
plant protection products on the market1, and in particular the fourth subparagraph of 
Article 8(2) thereof, 
Whereas: (1) Article 8(2) of Directive 91/414/EEC provi des that a Member State may, during a 
period of 12 years following the notification of  that Directive, authorise the placing on 
the market of plant protection products containing active substa nces not listed in 
Annex I of that Directive th at are already on the market two years after the date of 
notification, while those substances are gradually being examined within the framework of a programme of work. 
(2) Commission Regulations  (EC) No 1112/2002
2 and (EC) No 2229/20043 lay down the 
detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Directiv e 91/414/EEC and estab lish a list of active 
substances to be assessed with a view to their possibl e inclusion in  Annex I to 
Directive 91/414/EEC. That list includes nicotine. 
                                                
 
1 OJ L 230, 19.8.1991, p. 1. 
2 OJ L 168, 27.6.2002, p. 14.  
3 OJ L 379, 24.12.2004, p. 13. 4 (3) For nicotine the effects on human health a nd the environment have been assessed in 
accordance with the provisions laid down in Regulations (EC) No 1112/2002 and (EC) 
No 2229/2004 for a range of uses proposed by the notifier. Moreover, those Regulations designate the Rapporteur Memb er States which have to submit the 
relevant assessment reports and recomme ndations to the European Food Safety 
Authority (EFSA) in accordance with Article 20 of Regulation (EC) No 2229/2004. For nicotine the Rapporteur Member State was United Kingdom and all relevant information was submitted in January 2008. 
(4) The Commission examined nicotine in accordance with Article 24a of Regulation 
(EC) No 2229/2004. A draft review report fo r that substance was reviewed by the 
Member States and the Commission with in the Standing Committee on the Food 
Chain and Animal Health and finalised on 26 September 2008 in the format of the 
Commission review report. 
(5) During the examination of this active substance by the Committee, it was concluded, 
taking into account comments received from Member States, that the existing evidence is not sufficient to demonstrate a safe use with respect to operators, workers, 
bystanders and consumers. Moreover, othe r concerns which were identified by the 
rapporteur Member States in its assessment re port are included in the review report for 
the substance. 
(6) The Commission invited the notifier to submit its comments on the results of the peer 
review and on its intention or not to fu rther support the substance. The notifier 
submitted its comments which have been carefully examined. However, despite the arguments put forwards by the notifier, the concerns identified could not be 
eliminated, and assessments made on the ba sis of the information submitted have not 
demonstrated that it may be expected that , under the proposed conditions of use, plant 
protection products containing nicotine satisf y in general the requirements laid down 
in Article 5(1)(a) and (b) of Directive 91/414/EEC. 
(7) Nicotine should therefore not be include d in Annex I to Directive 91/414/EEC. 
(8) Measures should be taken to ensure that au thorisations granted for plant protection 
products containing nicotine are withdrawn wi thin a fixed period of time and are not 
renewed and that no new authorisations for such products are granted.  
(9) Any period of grace granted by a Member St ate for the disposal, storage, placing on the 
market and use of existing stocks of plant prot ection products containing nicotine should 
be limited to twel ve months in order to allow existing stocks to be used in one further 
growing season, which ensures that plant prot ection products containing nicotine remain 
available to farmers for 18 months from the adoption of this Decision. 
(10) This Decision does not prejudice the submi ssion of an applica tion for nicotine in 
accordance with Article 6(2) of Direc tive 91/414/EEC and Commission Regulation 
(EC) No 33/2008 of 17 January 2008 laying dow n detailed rules for the application of 
Council Directive 91/414/EEC as regards a re gular and an accelerated procedure for 
the assessment of active substances which were part of the programme of work 5 referred to in Article 8(2) of that Directiv e but have not been included into its Annex 
I4, in view of a possible inclusion in its Annex I.  
(11) The measures provided for in this Decision are in accordance with the opinion of the 
Standing Committee on the Food Chain and Animal Health, 
HAS ADOPTED THIS DECISION: 
Article 1 
Nicotine shall not be included as active s ubstance in Annex I to Directive 91/414/EEC. 
Article 2 
Member States shall ensure that: 
(a) authorisations for plan t protection products containi ng nicotine are withdrawn by [INSERT 
DATE 6 MONTHS FROM THE DATE OF ADOPTION OF THIS DECISION];  
(b) no authorisations for plant protection products containing ni cotine are gran ted or renewed 
from the date of publication of this Decision. 
Article 3 
Any period of grace granted by Member Stat es in accordance with the provisions of 
Article 4(6) of Directive 91/414/EEC, shall be as short as possible and shall expire on 
[INSERT DATA 18 MONTHS FROM ADOPTION OF THIS DECISION]  at the latest. 
                                                 
4 OJ L 15, 18.1.2008, p. 5. 6 Article 4 
This Decision is addressed to the Member States. 
Done at Brussels, 
 For the Commission 
 Androulla Vassiliou  Member of the Commission